Fierce Pharma
APRIL 19, 2023
Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04
PharmaVoice
APRIL 18, 2023
How an “international” childhood sent Dr. José Trevejo, Tarsus’s chief medical officer, on a mission to fight infectious diseases.
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Medgadget
APRIL 18, 2023
Researchers at MIT have developed lipid nanoparticles that are highly efficient at delivering mRNA therapies to lung cells. Getting therapeutic agents into the lungs can be challenging, but there are a variety of medical challenges that could be addressed by efficiently targeting lung cells with nanoparticle technologies. These latest particles are highly efficient at delivering mRNA which can then encode therapeutically useful proteins in the lungs.
MedCity News
APRIL 17, 2023
Innovaccer launched a new product called Sara, a conversational AI assistant designed to help executives at health systems and payers make better use of their data. It allows executives can ask complex questions about their organization’s patients or members and get immediate answers on clinical, financial or operational metrics.
Fierce Pharma
APRIL 21, 2023
In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35
European Pharmaceutical Review
APRIL 19, 2023
“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study. The treatment is indicated for patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation, following myeloablati
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
APRIL 21, 2023
By combining in-home and virtual care, we can meet patients literally where they are. More importantly, we can improve outcomes, reduce costs and help patients get back to a normal life while giving therapists the flexibility and opportunity to provide more customized care for their patients.
Fierce Pharma
APRIL 20, 2023
'The Top Line': How Pfizer became the first in Big Pharma history to break $100B in sales, plus this week's headlines tcarey Thu, 04/20/2023 - 14:46
PharmExec
APRIL 17, 2023
J&J's Janssen Pharmaceutica NV collaborates with Pipeline Therapeutics in a $50 million licensing deal for oral MS drug PIPE-307, with potential earnings of up to $1 billion for Pipeline.
Pharmaceutical Technology
APRIL 21, 2023
Moderna has signed an agreement with IBM to explore quantum computing and generative artificial intelligence (AI) for advancing and expediting its mRNA research. Moderna will gain access to IBM’s quantum computing systems, an emerging technology that harnesses quantum mechanics for solving complex problems that cannot be handled efficiently by classical computers.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
MedCity News
APRIL 18, 2023
Glen Tullman — CEO of care navigation company Transcarent, as well as former CEO of Allscripts and Livongo — discussed what he thinks the future of healthcare will look like during the HIMSS conference in Chicago. He laid out five predictions, including an increased focus on consumer expectations and more investment in AI.
Fierce Pharma
APRIL 19, 2023
J&J, Legend's Carvykti cut risk of progression or death by whopping 74% in earlier myeloma, leaked abstract shows aliu Wed, 04/19/2023 - 09:10
Copyright Clearance Center
APRIL 18, 2023
April 18, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, is hosting a panel discussion on “Reading the Data Compass: The Guiding Role of Metadata in an Increasingly Complex Scholarly Research Ecosystem” during the Research & Scholarly Publishing Forum at The London Book Fair on 20 April, 11:40 -12:10 in the Olympia Theatre.
Pharmaceutical Technology
APRIL 21, 2023
Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
MedCity News
APRIL 20, 2023
Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion.
Fierce Pharma
APRIL 18, 2023
Big Pharmas finally strike with GSK, Merck acquisitions, signaling accelerating pace of M&A aarmstrong Tue, 04/18/2023 - 09:47
PM360
APRIL 18, 2023
ISPOR—The Professional Society for Health Economics and Outcomes Research announced the plenary sessions and speakers for its annual international conference, ISPOR 2023. The conference is scheduled for May 7-10 in Boston, MA, USA with the theme, “Impacting Innovation, Value, and Healthcare Decision Making.” Plenary sessions for ISPOR 2023 include the following with speakers added to the online program as they are confirmed: Plenary 1: Global Focus on Affordability and Inward Investment – What
Pharmaceutical Technology
APRIL 21, 2023
The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
MedCity News
APRIL 19, 2023
With AI being so new, there are some best practices for companies to follow when bringing it into healthcare. This includes partnerships and understanding the shortcomings of AI, several experts said during a session at the HIMSS 2023 conference.
Fierce Pharma
APRIL 18, 2023
AbbVie's Qulipta gains edge on Pfizer's Nurtec with FDA approval to prevent chronic migraines zbecker Tue, 04/18/2023 - 11:09
Tribeca Knowledge
APRIL 17, 2023
I n our new report Market Access 2023, we consider how a rapidly changing market access environment presents the biopharm aceutical industry with complex challenges to launch success and enhanced patient outcomes. Without mastering these challenges, companies risk seeing potentially transformative products, nurtured through years of effort and investment, left stranded in limbo between market entry and uptake.
Pharmaceutical Technology
APRIL 20, 2023
Chinese firm Hasten Biopharmaceutic has raised $315m for business development of its pipeline assets in a financing round co-led by Singapore-based CBC Group and Abu Dhabi sovereign wealth fund Mubadala Investment, The funding round was supported by additional institutional investors. Hasten will also use the proceeds from the round to fund future acquisitions.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
MedCity News
APRIL 16, 2023
Modernizing the financial experience is about more than payment: it requires a comprehensive approach that includes pre-registration activities and extending the streamlined digital experience into the point of care.
Fierce Pharma
APRIL 17, 2023
In Pfizer's $43B acquisition of Seagen, the biotech's patience paid off kdunleavy Mon, 04/17/2023 - 11:34
PM360
APRIL 18, 2023
ISPOR—The Professional Society for Health Economics and Outcomes Research announced its ISPOR Real-World Evidence Summit 2023 scheduled for May 7 in Boston, MA, USA. The Summit is collocated with and being held immediately prior to the Society’s annual international conference, ISPOR 2023. The Summit is a collaboration between ISPOR, the International Society for Pharmacoepidemiology (ISPE), and the Duke-Margolis Center for Health Policy.
Pharmaceutical Technology
APRIL 20, 2023
European life sciences venture capital firm Forbion has raised €1.35bn ($1.47bn) across its two new funds. The latest fundraising brings the total funds managed by the company to €3bn ($3.28bn). The Forbion Ventures Fund VI and the Forbion Growth Opportunities Fund II both exceeded their original target sizes. The Forbion Ventures Fund VI’s final close reached the hard cap of €750m ($821.76m), while the Forbion Growth Opportunities Fund II secured €600m ($657.41m).
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
MedCity News
APRIL 20, 2023
Health technologies are often built based on the “reference man” and frequently don’t take other demographics into account. It shouldn’t be this way, experts argued on a panel Thursday at the HIMSS 2023 conference.
Fierce Pharma
APRIL 21, 2023
As Bayer's CEO switch nears, activist investor pushes harder for breakup, board changes fkansteiner Fri, 04/21/2023 - 10:25
European Pharmaceutical Review
APRIL 20, 2023
It has been nearly 20 years since a new treatment option has become available [for] newly diagnosed with diffuse large B-cell lymphoma [in the US]” The US Food and Drug Administration (FDA) has approved Polivy ® (polatuzumab vedotin-piiq) in combination with Rituxan ® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP). “It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” shared Dr Levi G
Pharmaceutical Technology
APRIL 18, 2023
IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.
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In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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